U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures (EPIOS)

July 17, 2026 updated by: Precision IO Group

Evaluation of the Epione Robotic System for Image-guided Percutaneous MSK Procedures of the Pelvis and Spine in USA. A Prospective Study on Feasibility, Safety and Accuracy

The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults.

The main question is the determination of the rate of feasible procedures assisted by the Epione device

Participants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be:

  • The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate
  • Additional CT or CBCT scans during the procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92093
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Baptist Hospital Of Miami, Inc
        • Contact:
        • Principal Investigator:
          • Gina Landinez, MD
        • Sub-Investigator:
          • Brian Shiro, MD
        • Sub-Investigator:
          • Ripal Gandhi, MD
        • Sub-Investigator:
          • Constantino Pena, MD
        • Sub-Investigator:
          • Govindarajan Narayanan, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • Jordan Tasse, MD
        • Sub-Investigator:
          • Bulent Arslan, MD
        • Sub-Investigator:
          • Lisa Rauschert, MD
        • Sub-Investigator:
          • Rehan Riaz, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients ≥22 years old,
  • Patients approved for CT- or CBCT-guided MSK procedure in the pelvis or spine (except the cervical area) under general anesthesia,
  • Patients who have signed an IRB-approved informed consent form
  • Patients approved for coverage by their insurance for routine costs involved in this standard of care procedure
  • Inclusion criteria linked to the freehand procedure have been discussed and validated

Exclusion Criteria:

  • Patients with contraindication to undergo general anesthesia,
  • Patients unable to maintain appropriate breathing control,
  • Patients requiring CT- or CBCT-guided percutaneous procedure on target areas other than those indicated
  • Patients unable to fully understand all relevant aspects of the clinical study necessary for their decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response,
  • Pregnant or breast-feeding women,
  • Patients subject to a legal protection measure,
  • Patients already participating in another conflicting interventional clinical study,
  • Patients for whom the scan field of view cannot contain the anatomy of interest, the overlaying skin surface, skin markers and the whole patient reference.
  • Patients having a coagulation abnormalities or bleeding disorder
  • Patients having an active infection on the day of intervention
  • Patients having a history of previous surgery resulting in an existing hardware precluding percutaneous approach
  • Exclusion criteria linked to the freehand procedure have been discussed and validated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT guidance
The procedure is performed under CT guidance.
Device: Percutaneous procedure in the MSK structures of the pelvis and/or the spine
The introducer placement is performed with the Epione device.
Experimental: CBCT guidance
The procedure is performed under CBCT guidance.
Device: Percutaneous procedure in the MSK structures of the pelvis and/or the spine
The introducer placement is performed with the Epione device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasability
Time Frame: 5 months
Rate of successful insertions of the introducer with the assistance of the Epione device.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Adverse Event
Time Frame: 6 months
Adverse event(s) (AE): all AEs (serious and non-serious, related and not related to the device or the procedure(s))
6 months
Accuracy
Time Frame: 5 months
Lateral and 3D deviations, being the distance (mm) between the tip of the inserted introducer in its final position and its orthogonal projection on the first planned trajectory (lateral deviation) and the distance (mm) between the tip of the inserted introducer in its final position and the tip of the first planned trajectory (3D deviation).
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Precision IO Group

Collaborators

ICUREsearch
Endpoint, LLC

Investigators

  • Principal Investigator: Sean Tutton, MD, UC San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA-BO-CIP-0130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Age, Sex, Ethnicity, Race will be shared

IPD Sharing Time Frame

by the end of the study

IPD Sharing Access Criteria

everyone, they will be described in the report and publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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